Current acceptable medical practice for treating cancer in an organ involves surgical removal of the afflicted organ. In the case of kidney tumors, for example, the afflicted kidney is surgically removed, especially if the tumor is malignant. Statistically, a relatively small percentage--estimated at about 20 to about 30 percent--of patients subject to surgical removal of a tumorous kidney experience sustained, favorable response to this form of therapy. A majority of patients in this category terminate from metastatic (secondary) cancer occurring outside the kidney. If persons suffering from kidney cancer are not permanently benefitted, additional or alternative modes of therapy requiring more radical procedures will have to be developed to act more effectively with the disease at its first presentation so that surgical removal of a diseased organ will not be the only acceptable treatment.
Some organ malignancies have been treated with toxic agents in situ. Some kidney malignancies, for example, have been treated with chemotherapeutic agents and biological agents which are toxic moieties derived from organic sources. However, as with some chemotherapeutic agents, biological agents can not be introduced into the general circulation of the host body in sufficient strength and/or quantity to achieve satisfactory therapeutic response in the diseased organ because their negative, toxic effects on other organs and tissues of the host body rival their positive, therapeutic effect in the diseased organ.
The majority of kidney cancer patients die from metastatic disease. One promising method of treatment involves encouraging the growth of immune cells; i.e., Tumor Infiltrating Lymphocytic cells (TIL cells), within the kidney to attack metastatic tumors. The goal of this treatment is to shrink the kidney tumor prior to removing the kidney.
Another therapeutic procedure for organs with local tumors, sucl as the kidney, includes the surgical removal of tumorous matter from the organ an cultivating TIL cells in sufficient quantity for infusion into the patient for therapeutic treatment of metastatic tumors. The cultured cells may react favorably against both the primary tumor cells and any metastatic cancer cells in the body. However, time is needed in order to cultivate a sufficient quantity of such cells for adequate and effective treatment of a patient and the patient may not have the time required for such cultivation.
In general, treating diseased or tumorous organs with chemotherapeutic agents has not had a dramatic impact. Although certain drugs and biological agents have exhibited considerable activity in some treatment protocols, their effects have been negated by systemic toxicity.
A process for treating a diseased liver by profusing a high concentration of a therapeutic agent through the liver is disclosed in U.S. Pat. No. 5,069,662 to Bodden, et. al. This process includes percutaneously inserting a double balloon catherer into the inferior vena cava of the liver to prepare for delivery of blood flowing between the liver and the heart. A therapeutic agent is fed into the liver through the arterial blood flowing into the liver. The blood vessels carrying blood from the liver are blocked by inflating the balloons in the catherer to prevent contaminated blood from entering the general circulation of the body. The venous blood from the liver contaminated with the therapeutic agent is then withdrawn from the body. The balloons in the double balloon catherer are positioned to span the exit vessels through which blood flows coming out of the liver and are expanded to block the vessel above and below the exit vessels thereby effectively isolating the blood flowing from the treated liver. Contaminated blood is removed from the body through an opening in a lumen provided within the catherer between the expanded balloons. The blood is treated to remove contamination and the cleaned, detoxified blood is then returned to the general circulation of the body.